Medical devices - ISO 18562: Biocompatibility evaluation of breathing gas pathways

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Farmaceutiske produkter og medicinske utensilier

Medical devices - ISO 18562: Biocompatibility evaluation of breathing gas pathways

Biocompatibility evaluation of breathing gas pathways

Breathing gas pathways of medical devices that are used in healthcare applications have to be assessed according to ISO 18562:2017: Biocompatibility evaluation of breathing gas pathways in healthcare applications.

The standard applies to new medical devices as well as existing breathing gas pathways of medical devices that already are on the market. The deadline for the latter was the end of 2020.

The requirements apply to all breathing gas pathways of medical devices irrespective of wherever they are sold.


How can Danish Technological Institute help you with biocompatibility evaluation of breathing gas pathways

We can test the following breathing gas pathways of medical devices:

  • According to ISO 18562-2: Tests for emissions of particulate matter
  • According to ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs)
  • According to ISO 18562-4: Tests for leachables in condensate
  • In co-operation with an external consultant, Danish Technological Institute can facilitate the involvement of experienced consultants for standard analyses. The consultants can give advice and help prepare the correct analysis programme and carry out risk assessments.

The laboratory is accredited according to ISO/IEC 17025:2017

 

Examples of gas breathing pathways are: ventilators, anesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low pressure hose assemblies, humidifiers, heat and moisture exhangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breating system filters, Y-pieces, breathing accesories intended to be used with the equipment, the enclosed chamber of an incubator, including the mattress and the inner surface og an oxygen hood.